Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV, (NCT03164135)

Disease info:

Human immunodeficiency virus (HIV) is a virus that attacks the immune system by infecting and killing white blood cells known as CD4+ T-cells. CD4+ T-cells represent a vital part of the immune system and untreated HIV infections render patients more vulnerable to dangerous infections by other pathogens, including bacteria and fungi. If the virus remains untreated it can lead to patients developing the life-threatening disease acquired immunodeficiency syndrome (AIDS). Untreated HIV can leave people vulnerable to life-threatening infections. HIV symptoms often manifest as flu-like symptoms such as fever, chills, rash, night sweats, muscle aches, sore throat, and fatigue. Today, antiviral medications can allow people living with HIV to live healthy lives.

 

 

 

 

Frequency:
In 2021, 36,136 people received an HIV diagnosis in the United States and dependent areas. An estimated 1.2 million people in the United States had HIV at the end of 2021.
Official title:
Safety and Feasibility Study of Allotransplantation of CRISPR/Cas9 CCR5 Gene Modified CD34+ Hematopoietic Stem/Progenitor Cells in HIV-infected Subjects With Hematological Malignances.
Who:

Contact

 

Name: Bin Zhang, MD, PhD

Phone: +86-10-66947625

Email: zb307ctc@163.com


Name: Hu Chen, MD, PhD

Phone: +86-10-66947108

Email: chenhu217@aliyun.com

Sponsor:

Affiliated Hospital to Academy of Military Medical Sciences

Locations:

China, Beijing

307 Hospital of PLA (Affiliated Hospital of Academy to Military Medical Sciences), Beijing, Beijing, China, 100071

Study start:
May. 30, 2017
Enrollment:
5 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene ablation
Gene:
C-C motif chemokine receptor 5 (CCR5)
Delivery method:
non-viral - Ex-vivo
Note:
Phase not applicable
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown

Description

The investigators performed this study to evaluate the safety and feasibility of transplantation with CRISPR-Cas9 CCR5 gene modified CD34+ hematopoietic stem/progenitor cells for patients that develop AIDS and hematological malignances. Patients will be treated with antiviral therapy (ART) to achieve undetectable HIV-1 virus in peripheral blood before conditioning. CD34+ cells from donors will be infused into the patients after treatment with CRISPR-Cas9 to ablate CCR5 gene.

Last updated: Dec. 28, 2023
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